Under the FDA (Food & Drug Administration) rule in the USA, manufacturers have been required to implement UDI (unique device identification) on all medical product …

In the 2017 fiscal year, the FDA issued 114 warning letters to pharmaceutical manufacturers contravening Current Good Manufacturing practices (cGMPs). This followed a trend of …

Pharmacovigilance (PV) is a vital part of healthcare and for monitoring the benefit-risk profile of medicinal products. The purpose of the European Medicines Agency’s (EMA’s) …

This article by Trishna Chetry, T.M. Pramod Kumar, M.P. Venkatesh and Balamuralidhara V. from JSS College highlights the complex and critical regulatory strategies adopted by …

The entire process from discovering and developing a potential drug candidate to its delivery into the human body requires comprehensive knowledge about the root cause of …

A variety of in vivo, in silico, in vitro, and ex vivo model systems are available to researchers for studying the human intestinal microbiome, its …

Obesity is a major concern for governments worldwide. In the UK alone, it is estimated that the direct costs of obesity to the National Health …

“Sepsis is the most preventable cause of death”, and every hour it is not diagnosed will increase the probability it will kill the patient by …

Stem cells attract a great deal of attention due to their developmental potential and lineage-independent characteristics. Adult stem cells, otherwise known as inducible pluripotent stem …

The human heart is one of nature’s engineering marvels, considering the requirement specifications for this fist-sized hollow organ that only weighs 250–300 grams. Delivering about …